Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K053531
Device Name DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JIT  
Date Received12/19/2005
Decision Date 03/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-